TARGAXAN 550mg film-coated tablets

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

By reporting side effects you can help provide more information on the safety of this medicine.

Marketing Authorisation Holder (UK):

Norgine Pharmaceuticals Limited

Norgine House, Widewater Place,

Moorhall Road, Harefield, Uxbridge,

UB9 6NS, UK

Marketing Authorisation Holder (IE):

Norgine B.V.

Antonio Vivaldistraat 150,

1083HP Amsterdam

Netherlands

This leaflet was last revised in 07/201903/2020

Updated on 15 October 2019 PIL

Reasons for updating

Change to section 4 - how to report a side effect

Updated on 15 October 2019 PIL

Reasons for updating

Change to section 6 - manufacturer

Updated on 5 April 2019 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Updated on 5 April 2019 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 October 2018 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Change to section 6 - marketing authorisation number

Change to section 6 - date of revision

Updated on 25 October 2018 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Change to section 8 - Marketing authorisation number(s)

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 September 2017 PIL

Reasons for updating

Change to section 6 - manufacturer

Change to section 6 - date of revision

Updated on 15 September 2017 PIL

Reasons for updating

New PIL for new product

Updated on 21 October 2016 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 October 2016 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 and section 4.5 are updated to included warning on warfarin

Updated on 22 December 2015 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to side-effects

Change to drug interactions

Change to date of revision

Addition of information on reporting a side effect.

Correction of spelling/typing errors

Updated on 22 December 2015 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Due to the effects on the gut flora, the effectiveness of oral oestrogenic contraceptives could decrease after rifaximin administration. However, such interactions have not been commonly reported. It is recommended to take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 mg (see also section 4.5).

Caution should be exercised when concomitant use of rifaximin and a P-glycoprotein inhibitor such as ciclosporin is needed (see section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

There is no experience regarding administration of rifaximin to subjects who are taking another rifamycin antibacterial agent to treat a systemic bacterial infection.

In vitro data show that rifaximin did not inhibit the major cytochrome P-450 (CYP) drug metabolizing enzymes (CYPs1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4). In in vitro induction studies, rifaximin did not induce CYP1A2 and CYP 2B6 but was a weak inducer of CYP3A4.

In healthy subjects, clinical drug interaction studies demonstrated that rifaximin did not significantly affect the pharmacokinetics of CYP3A4 substrates, however, in hepatic impaired patients it cannot be excluded that rifaximin may decrease the exposure of concomitant CYP3A4 substrates administered (e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives), due to the higher systemic exposure with respect to healthy subjects.

An in vitro study suggested that rifaximin is a moderate substrate of P-glycoprotein(P-gp) and metabolized by CYP3A4. It is unknown whether concomitant drugs which inhibit P gp and/or CYP3A4 can increase the systemic exposure of rifaximin.

In healthy subjects, co-administration of a single dose of ciclosporin (600 mg), a potent P-glycoprotein inhibitor, with a single dose of rifaximin (550 mg) resulted in 83-fold and 124-fold increases in rifaximin mean Cmax and AUC∞. The clinical significance of this increase in systemic exposure is unknown.

The potential for drug-drug interactions to occur at the level of transporter systems has been evaluated in vitro and these studies suggest that a clinical interaction between rifaximin and other compounds that undergo efflux via P-gp and other transport proteins is unlikely ( MDR1, MRP2, MRP4, BCRP and BSEP).

4.8 Undesirable effects

Table 2 includes adverse reactions observed in the placebo-controlled study RFHE3001, and long term study RFHE3002 and from post-marketing experience, listed by MedDRA system organ class and frequency category.

Anaphylactic reactions, angioedemas, hypersensitivity have been moved form MeDRA System Organ Class 'Nervous system disorders' to 'Immune system disorders'.
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Reporting of suspected adverse reactions